An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Pregabalin 75 mg Duloxetine as delayed release 30 mg capsule of Signature Phytochemical Industries in comparison with Pregalin D 75/30 Pregabalin 75 mg Duloxetine as delayed release) 30 mg Capsule of Torrent Pharma Ltd., in healthy adult human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the PK parameter Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
An open label, balanced, randomized,two-treatment, two-period, two-sequence, single oral dose, crossover,bioequivalence study of Pregabalin 75 mg + Duloxetine (as delayed release) 30mg capsule of Signature Phytochemical Industries in comparison with Pregalin D75/30 {Pregabalin 75 mg +Duloxetine (as delayed release) 30 mg Capsule} of Torrent Pharma Ltd., inhealthy, adult, human subjects under fasting condition.
Primary objective:
To compare the rate and extent of absorption of Pregabalin75 mg + Duloxetine (as delayed release) 30 mg capsule of SignaturePhytochemical Industries with that of Pregalin D 75/30 {Pregabalin 75 mg + Duloxetine (as delayed release) 30 mgCapsule} of Torrent Pharma Ltd., in healthy, adult, human subjects under fastingcondition.
Secondary objective:
Tomonitor the safety and tolerability of the study subjects after administrationof Pregabalin 75 mg + Duloxetine (as delayed release) 30 mg capsules in healthy,adult, human subjects under fasting condition.
24 subjects will be enroll in the study . The study duration is 11 days .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2.Willing to be available for the entire study period and to comply with protocol requirements.
- •3.Male subjects have to agree to use condoms during sexual intercourse with a woman of childbearing potential for at least 10 weeks (one complete sperm cycle) after the last dose of study drug.
- •4.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
排除标准
- •1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
- •2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •3.History of severe infection or major surgery in the past 6 months.
- •4.History of Minor surgery or fracture within the past 3 months.
结局指标
主要结局
To evaluate the PK parameter Cmax, AUC0-t and AUC0-∞
时间窗: Day 1 to Day 11
次要结局
- 1. Monitoring of safety of IP(2. Tmax , AUC_%Extrap_obs, λz and t1/2)